U.S. patent application number 15/901185 was filed with the patent office on 2018-06-28 for hand-held actuator device.
The applicant listed for this patent is C. R. Bard, Inc.. Invention is credited to Jurgen Dorn, Michael Vogel, Martin Wubbeling.
Application Number | 20180177621 15/901185 |
Document ID | / |
Family ID | 37027359 |
Filed Date | 2018-06-28 |
United States Patent
Application |
20180177621 |
Kind Code |
A1 |
Dorn; Jurgen ; et
al. |
June 28, 2018 |
HAND-HELD ACTUATOR DEVICE
Abstract
A hand-held actuator device for releasing into the body from a
delivery system a medical prosthesis, like a stent, comprising a
frame that acts as a housing, a reel for receiving a wire, a
manually operable slider mounted to the frame and a one-way
connection between the slider and the reel. Actuating the slider
causes the reel to wind up the wire and release the medical
prosthesis.
Inventors: |
Dorn; Jurgen; (Neulussheim,
DE) ; Wubbeling; Martin; (Mannheim, DE) ;
Vogel; Michael; (Karlsruhe, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
C. R. Bard, Inc. |
Tempe |
AZ |
US |
|
|
Family ID: |
37027359 |
Appl. No.: |
15/901185 |
Filed: |
February 21, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14793669 |
Jul 7, 2015 |
9901469 |
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15901185 |
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12376670 |
Feb 6, 2009 |
9078779 |
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PCT/EP2007/058205 |
Aug 7, 2007 |
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14793669 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/95 20130101; A61F
2/9517 20200501; A61F 2/92 20130101; A61F 2/962 20130101; A61F
2/966 20130101; A61M 25/0147 20130101; A61M 2025/015 20130101 |
International
Class: |
A61F 2/95 20130101
A61F002/95; A61F 2/962 20130101 A61F002/962; A61F 2/966 20130101
A61F002/966 |
Foreign Application Data
Date |
Code |
Application Number |
Aug 7, 2006 |
GB |
0615658.2 |
Claims
1-21. (canceled)
22. A device, comprising: a frame; a reel mounted to the frame; a
slider mounted to the frame; and a connection that engages the
slider and the reel during a backward stroke.
23. The device of claim 22, further comprising a detent that sits
on the frame and that engages the reel.
24. The device of claim 23, wherein the detent comprises a
resilient finger.
25. The device of claim 24, wherein the detent guides the wire
toward the reel.
26. The device of claim 25, wherein the detent comprises a pawl
that engages the reel.
27. The device of claim 26, further comprising a track mounted to
the frame, and a lock that locks the slider to the track.
28. The device of claim 27, wherein the slider further comprises a
carriage that slides along the track.
29. The device of claim 28, wherein the wire connects to the
reel.
30. The device of claim 29, wherein the slider comprises teeth and
the reel or an element connected to the reel comprises cooperating
teeth.
31. The device of claim 30, wherein the teeth engage during the
backward stroke and that disengage during the forward stroke.
32. The device of claim 31, further comprising: a catheter having a
proximal end joined to a distal end of the frame; a sheath disposed
coaxially inside the distal end of the catheter and attached to the
wire; and a self-expanding stent mounted in the sheath.
33. A device, comprising: a frame; a reel mounted to the frame; a
slider mounted to the frame; a connection that engages the slider
and the reel during a backward stroke and that disengages during a
forward stroke; and a detent that sits on the frame and that
engages the reel.
34. The device of claim 33, wherein the detent comprises a
resilient finger.
35. The device of claim 34, wherein the detent guides the wire
toward the reel.
36. The device of claim 35, wherein the detent comprises a pawl
that engages the reel.
37. The device of claim 36, further comprising a track mounted to
the frame.
38. The device of claim 37, wherein the slider further comprises a
carriage that slides along the track.
39. The device of claim 38, wherein the slider comprises teeth and
the reel or an element connected to the reel comprises cooperating
teeth.
40. The device of claim 39, further comprising: a catheter having a
proximal end joined to a distal end of the frame; a sheath disposed
coaxially inside the distal end of the catheter and attached to the
wire; and a self-expanding stent mounted in the sheath.
41. A device, comprising: a frame; a reel mounted to the frame; a
slider mounted to the frame; a connection that engages the slider
and the reel during a backward stroke and that disengages during a
forward stroke; and a brake, wherein, the reel rotates in a first
direction, and the brake opposes reel rotation in a direction
counter to the first direction.
Description
[0001] This application is a divisional of U.S. application Ser.
No. 12/376,670, filed Feb. 6, 2009, now U.S. Pat. No. 9,078,779,
which is a U.S. national stage application under 35 U.S.C. .sctn.
371 of International Application No. PCT/EP2007/058205, filed Aug.
7, 2007, claiming priority to Great Britain Patent Application No.
0615658.2, filed Aug. 7, 2006, each of which is incorporated by
reference in its entirety into this application.
FIELD OF THE INVENTION
[0002] The present invention relates generally to a catheter based
system for treating a remote location within a patient and more
particularly to the hand-held actuator devices of stent delivery
systems.
BACKGROUND
[0003] A delivery system for a self-expanding stent usually has the
stent distally adjacent to a tube, both within a sleeve at the
distal end of a catheter. To deliver the stent, the sleeve has to
be pulled back while the tube holds the stent from moving back with
the sleeve. Therefore, the tube is placed adjacent to the stent and
acts as a barrier and restrains the stent from moving while the
sleeve is pulled back.
[0004] WO 02/087470 discloses a hand device for a catheter stent
delivering system. The hand device can be operated one-handed to
ease the operation with such a device. The main function such
devices have to include are: [0005] 1) to pull back the sleeve, for
example by pulling a wire which is connected to the proximal end of
the outer sleeve; [0006] 2) to restrain simultaneously the inner
tube from being pulled back together with the sleeve; and [0007] 3)
to provide a visual signal of how much length of the sleeve has
already been pulled back
[0008] The restraint function can be performed by a hub that is
mounted within the hand-held actuator and itself receives the
proximal end of the tube. To pull the wire, in WO 02/087470 is
provided an index-finger-triggering-system, which causes a
mechanical apparatus within the device to pull in the wire and draw
the proximal end of the sleeve into the housing of the hand unit. A
disadvantage of the index-finger-triggering-system is that it is a
pistol-like device and the impression it gives to the operator, of
direct tactile feedback about the progress of stent release, some
operators might find unconvincing. Furthermore, the maximum length
of wire, which can be reeled in by successive squeezes of the
trigger, is defined by the length of the. track in the hand unit
along which the proximal end of the sleeve advances proximally,
rendering it incapable of releasing a self-expanding stent which is
longer than the track.
[0009] EP 1 299 050 discloses a thumb-actuating-screwing-system,
but this has all disadvantages of the
index-finger-triggering-system. In addition the thumb has to be
lifted between every turn of the screw, which makes the control of
the pull-mechanism less comfortable.
[0010] Both of the above identified systems have a component
protruding from the housing of the hand unit, which moves
proximally through the device with the catheter being withdrawn,
and so acts as a distance indicator. When the operator starts
coiling-up the wire, the indicator moves and the operator and his
or her assistants can judge the extent of the progressive stent
release from the distance the indicator has travelled proximally
along the length of the housing of the hand unit.
[0011] Stents are getting longer (e.g. in a leg the stent can be
about 30 cm). It is one object of the present invention to provide
a hand-held actuator for release of a self-expanding stent with a
length longer than can be handled by the known hand-held
actuators.
[0012] Generally, the present invention aims to improve on the
performance of the devices of WO 02/087470 and EP 1 299 056, in the
respects mentioned above.
SUMMARY OF THE INVENTION
[0013] According to the present invention there is provided a
device for releasing into the body from a delivery system a medical
prosthesis, like a stent, of the form discussed herein. Optional or
preferred features of the invention are mentioned in the
claims.
[0014] In a first preferred embodiment, the device comprises a
frame, which can be moulded of plastic and acts as housing. At its
distal end a hub is provided, which acts as an abutment system for
the tube. A slider is connected in a one-way connection to a reel,
which is caused to rotate by a pull stroke of the slider. The reel
winds a portion of a length of the wire by every pull stroke and
holds the position by every return stroke. A detent restrains the
reel from moving during a return stroke, so the reel is urged to
move in only one direction.
[0015] In a second embodiment the slider is formed as a thumb pad
and has a carriage portion on his flanks. It slides on a track,
which is defined by the frame. In a rest position, the slider is
restrained from sliding by a slider release element, which is
located within the thumb pad and which prevents the wire
inadvertently being pulled proximally. In the restraining initial
position the slider release element protrudes from the carriage
portion of the slider. The slider release element can be urged in a
second release position, which allows the slider to move free on
the track.
[0016] Particularly when the slider slides on a track in a
direction parallel to the axis of the catheter, the operator has
the sensation that the thumb pad delivers useful tactile feedback
about what happening at the distal end of the catheter, where the
stent is being released.
[0017] In a third embodiment, the one-way connection comprises
teeth on a elongation of the slider element and co-operating teeth
on a rotatory element which is operatively connected to the reel.
The one-way connection could be located between the teeth of the
slider and the rotatory element. In this case the teeth are formed
such that they engage in one way and slip over in the reverse
direction. Such embodiment can enhance the sensation of tactile
feedback to the operator, through the wire and reel to the
slider.
[0018] In another embodiment the detent is formed as a pawl to
engage with the reel or, more specifically, with the teeth of the
rotatory element, to restrain it from moving in the reverse
direction. This finger preferably points in the rotatory direction
of the wheel. In another construction of the detent a finger
engages with the wire such that the finger pushes the wire onto the
reel. In this case the restraining force comes from the resilience
of the wire in addition to the friction between the wire and the
finger. In a further embodiment, the detent comprises both the pawl
and the finger. Embodiments that include such a pawl can provide
audible feedback to the operator (and others working with the
operator}, in the form of clicking sounds, about the rate of
progress of the stent release operation.
[0019] These embodiments can be used with stent delivery catheters,
both `over the wire` and `rapid exchange`. They can be used
regardless whether it is the inner or the outer element of the
co-axial shaft of the catheter which is proximally withdrawn
relative to the other to release the stent. A catheter system which
employs the inner of two co-axial shaft elements to pull proximally
back a sheath that surrounds a self-expanding stent at the distal
end of the catheter is called a `pull-wire` stent delivery
catheter. Such a pull wire system is useful for delivering
ultra-long stents, because the reel can accommodate a length of the
pull wire longer than the stent, however long the stent is.
[0020] The described embodiments need very few mechanical elements.
This avoids unnecessary waste and minimizes assembly time and
weight of the device. Furthermore, with the pull wire of the
catheter system connected directly to the reel there is no limit to
the length of wire that can be withdrawn proximally. With
relatively short stents, when placement in the body is delicate,
the slider can still act as an indicator of stent release progress,
and how much of the stent length is still to be released.
[0021] The design of the device can be formed ergonomically such it
is comfortable for every hand size of any operator. In addition,
the thumb of the gripping hand falls naturally on the thumb pad of
the slider.
[0022] Recapitulating some advantages of the present invention over
the above mentioned prior art systems are: [0023] better tactile
feedback about the stent delivery progress [0024] no limitation of
the stent length, with simultaneous [0025] visual information about
the stent delivery progress stepless wire-pulling and audible
feedback of the operation progress [0026] improved handling through
ergonomic design reduced number of mechanical components
BRIEF DESCRIPTION OF THE FIGURES
[0027] FIG. 1 shows a longitudinal section of a preferred
embodiment;
[0028] FIG. 2 shows a transverse section along the line II-II in
FIG. 1;
[0029] FIG. 3 shows a transverse section along the line III-III in
FIG. 1;
[0030] FIG. 4 is a side view to show a borehole and a groove in the
cylindrical drum of the reel;
[0031] FIG. 5 is a front view of the drum of FIG. 4;
[0032] FIG. 6 is a side view of an end of the wire; and
[0033] FIG. 7 is a section along the line IV-IV in FIG. 3 seen from
above.
DETAILED DESCRIPTION
[0034] The invention can be embodied in a device for pulling a wire
8 out of a tube 14 and which can be activated, preferably with only
one hand.
[0035] The drawings show a preferred embodiment of the invention.
FIG. 1 shows one half of a molded housing 10 which serves as a
frame for mounting the various components of the device, and has a
proximal end 20 and a distal end 22. The housing is almost
symmetric and the two half housing parts are fixed together with
screws 18 (or something similar like rivets or plugs) at defined
places. A portion of each half of the housing is covered with a
rubber material (not shown). This increases the grip and eases the
handling of the device.
[0036] A first hub 12 is fixed at the distal end 22 of the housing,
acting as an abutment and bearing element for guiding the tube 14
to the housing 10. The tube 14 terminates in the hub 12, so that a
wire 8 can be pulled out of the tube. The hub 12 acts as an
abutment element and stops the tube 14 from being pulled into the
housing 10. Through this abutment element extends an inner tube 26
to a second hub 24 at the proximal end 20 of the housing 10. The
second hub 24 provides a female luer connector to engage a
corresponding male luer, for flushing liquid for the lumen of the
tube 14.
[0037] A reel 30 is provided to take up the wire 8 and is
preferably near the proximal end 20 of the housing 10 rotatably
mounted in the housing. The reel is flanked by two large discs 30a,
30b, spaced apart by a cylindrical drum surface 30c of the reel for
the wire. Both of the discs have a toothed circumferential surface
to provide a ratchet element (see FIG. 3). In other embodiments
there could be only one smooth wheel and one ratchet wheel instead
of both wheels being ratchet wheels.
[0038] The reel coils up the wire when it rotates in the direction
of arrow A and would release the wire if it were able to rotate in
the opposite direction.
[0039] To attach the wire 8 to the reel 30 there is provided a
special ball-end on the wire and 8 a borehole in the drum
[0040] With reference to FIGS. 4, 5 and 6 a borehole 31 is provided
in the cylindrical drum 30c. The borehole 31 leads from the surface
of the cylindrical drum 30c, in a direction transverse to the
rotatory axis into the drum 30c, to an abutment surface 31c. A
groove 33 co-axial with the borehole 31 links the borehole with the
surface of the drum.
[0041] The end of the wire 8 carries a sleeve 9 and a ball Ba,
welded to the end of the wire 8. The wire B is put with the free
end into the sleeve 9 and the ball Sa stops the wire 8 from sliding
through the sleeve 9. Another way fixing the 8 sleeve 9 to the wire
8 could be to weld the ball Sa on the wire 8 after putting it
through the sleeve 9.
[0042] In another embodiment the wire and the sleeve are pressed
together such the sleeve 9 is fixed on the wire.
[0043] The wire 8 is threaded into the groove 33 and the sleeve 9
is advanced into the borehole 31. Pulling the wire urges the sleeve
to slide into the first borehole 31a, which has a diameter slightly
bigger than the sleeve 9, and blocks the wire from being pulled
further.
[0044] To avoid releasing a coiled up wire, a backstroke-stopper 32
(otherwise called `detent`) is provided near the reel 30. In the
preferred embodiment the stopper has two fingers. The first is a
detent 32a which functions as a pawl by engaging the teeth of the
ratchets 30a and/or 30b. The teeth of the ratchets are so shaped
that the finger 32a does not prevent the ratchet from rotating in
direction A, but stops the reel rotating in the other direction by
engaging into a gap between adjacent teeth.
[0045] The second finger 32b serves to press the already coiled
wire towards the rotational axis of the reel. The wire is springy
so it tends to straighten when it can and so will tend to unroll
from the reel. The second finger prevents this happening.
Preferably the second finger 32b has a recess 32ba (as shown in
FIG. 2) facing the wire to receive the wire 8. When the second
finger 32b presses down the wire 8, there is friction between the
wire and the finger. This friction, together with the resilience of
the wire, can act as a brake in the rotation of the reel. Indeed,
such a brake can render any ratchet and pawl superfluous. One
advantage of a brake over a ratchet in that one can achieve a
stepless pulling of the wire 8.
[0046] To urge the reel to rotate to wind in the wire 8, in
direction A, a slider 34 is provided. This slider has a thumb pad
35 and is operably connected to the reel by its elongate extension
36 that has a toothed straight ratchet profile 38 at its end remote
from the thumb pad. The toothed straight profile 38 and the toothed
ratchet on the periphery of each of the reel discs 30a, 30b provide
a one-way-connection 40 in which the reel rotates when the slider
is moved in the direction of arrow B. When the discs are so urged
to rotate, the drum 30c between the two discs is also rotating and
the wire is coiled up. When the slider is urged in the reverse
direction, arrow C, the teeth of the straight ratchet slide over
the teeth of the discs (see 40). In another embodiment the straight
ratchet and the discs may be fixedly connected such that both move
together, in both directions. A one-way bearing in the hub of the
reel allows the wire take-up reel to rotate in the direction of
arrow A, but not in direction of arrow B. Of course the movement
directions of the particular elements are changeable at will. For
example, if the wire coils up anti-clockwise on the reel, rather
than clockwise, each would be arranged the other way.
[0047] The slider slides on a track 42, defined by the housing 10.
The slider includes a slider release element 44, that is moveable
between a relaxed gripping disposition and a pushed down release
disposition. The release element, when not pushed down, is formed
such that a detent 44a of the slider release element is blocked by
a recess 46 the housing (as shown in FIG. 7). This restrains
inadvertent sliding of the slider. When the slider is to be moved,
the slider release element is first pushed down until the detent
engages the corresponding locker element 34aa on the inner part of
the slider 34a and is being held down. As a result the slider 34 is
released from the recess 46 in the housing and is free to move
along the track 42.
[0048] In another embodiment there could be provided a distance
scale (not shown) next to the sliding track advancing the distance
indication by the slider.
[0049] In another embodiment, there is provided a spring (not
shown) in the housing 10, which is connected to the slider and
urges the slider to slide back into the first pull back position
automatically.
[0050] As soon as the slider release element 44 is no longer pushed
down, it moves up again as a result of its resilience and the ramps
44a and 34aa, once again to restrain slider movement.
[0051] In the present embodiment all device members (reel, housing,
slider, head, hub and stopper) are molded from plastics. In other
embodiments components can be provided as separate individual parts
(e.g. the reel in one smooth, smaller wheel and two ratchets).
These parts can be formed of various materials (e.g. metal,
different kinds of plastics) and assembled (by screwing, plugging,
welding, riveting) as desired.
* * * * *